The following data is part of a premarket notification filed by Heartport, Inc. with the FDA for Heartport Endocoronary Sinus Cathetr.
| Device ID | K964248 |
| 510k Number | K964248 |
| Device Name: | HEARTPORT ENDOCORONARY SINUS CATHETR |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | HEARTPORT, INC. 200 CHESAPEAKE DR. Redwood City, CA 94063 |
| Contact | Kevin F Macdonald |
| Correspondent | Kevin F Macdonald HEARTPORT, INC. 200 CHESAPEAKE DR. Redwood City, CA 94063 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-24 |
| Decision Date | 1997-01-22 |
| Summary: | summary |